EMA acceptance of peginesatide MAA triggers $5M milestone payment to Affymax
Published on February 27, 2012 at 9:49 AM
Affymax, Inc. (Nasdaq: AFFY) today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide. The milestone is triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for the investigational compound peginesatide for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.
“We are delighted with Takeda's execution on the European front and are encouraged by the EMA acceptance of the MAA”
"We are delighted with Takeda's execution on the European front and are encouraged by the EMA acceptance of the MAA," said John Orwin, president and CEO of Affymax. "While we are concurrently preparing for potential commercialization of peginesatide in the United States, we are pleased that progress is being made to potentially make the product available outside the U.S."
Peginesatide was discovered by Affymax, and if approved, will be co-marketed by Affymax and Takeda in the United States. Takeda has commercialization rights in the European Union. In the United States, the scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.